CHICAGO, Sept. 18 /PRNewswire/ -- Astellas Pharma US, Inc. and
Theravance, Inc. (Nasdaq: THRX) announced today results with the
investigational compound telavancin from the largest subset of
surgical-site-associated complicated skin and skin structure infections
(cSSSIs) from a controlled Phase 3 clinical program in patients with
complicated Gram-positive cSSSIs, and results from preclinical and
surveillance studies were recently presented at the 47th annual
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
meeting in Chicago, Illinois.

Telavancin is a novel lipoglycopeptide injectable antibiotic discovered
by Theravance that was engineered to have a unique, multifunctional
mechanism of action; it inhibits the formation of the bacterial cell wall
and disrupts bacterial cell membrane function. Telavancin is currently
being evaluated by regulatory authorities in the United States and Europe
for its safety and efficacy in the treatment of complicated skin and skin
structure infections and is in Phase 3 studies for the treatment of
hospital-acquired pneumonia.

The following clinical activity of telavancin was reported at ICAAC.
New data from an analysis of a subset of nearly 200 patients with
surgical-site-associated complicated skin and skin structure infections
(cSSSIs) suggest that once-daily telavancin is clinically active in
surgical-site-associated cSSSIs due to Staphylococcus aureus, including
methicillin-resistant Staphylococcus aureus (MRSA). These data are from the
ATLAS (Assessment of TeLAvancin in complicated Skin and skin structure
infections) studies and represent the largest subset of
surgical-site-associated cSSSIs from controlled clinical trials. In these
studies, investigators compared clinical and microbiological responses from
treatment with telavancin and vancomycin. In this subset, clinical cure,
bacterial eradication and overall response rates were typically higher for
telavancin.

Staphylococcus aureus is a common cause of surgical-site infections.
Physicians report an increased proportion of these infections due to MRSA,
a serious, potentially life-threatening infection that is becoming
increasingly resistant to current treatments.

"Surgical site infections are a significant cause of death following
surgery, and while vancomycin is a mainstay for treatment of these
infections caused by MRSA, its decreasing effectiveness highlights the need
for new antibiotics," said Samuel E. Wilson, MD, Professor of Surgery,
University of California Irvine School of Medicine. "We are hopeful that
telavancin will be a safe and useful treatment for serious and
life-threatening complicated skin and skin structure infections."

Multiple Studies Support Telavancin

In addition to the analysis of a subset of patients with surgical site
infections, 13 other telavancin abstracts were accepted at this year's
ICAAC meeting. These data from multiple studies, taken in their entirety,
provide insight into the potential benefits of telavancin. Abstracts
included:

-- Comparative Use of Telavancin and Daptomycin Against MRSA in the

Neutropenic Murine Thigh Model

In this study, mice thigh tissue was injected with MRSA and dosed with

The ATLAS studies were two separate but identical, randomized,
double-blind trials to evaluate the efficacy and safety of telavancin
versus vancomycin in patients with cSSSIs, especially those due to MRSA. In
the ATLAS studies, telavancin contained the largest subset of patients over
18 years old with surgical-site associated cSSSIs of any randomized,
double-blind study to date. The most common adverse events reported in
patients receiving telavancin were mild to moderate taste disturbance and
nausea. In addition, consistent with previous studies, small percentages of
telavancin-treated patients experienced renal adverse events or increases
in the QTc interval. In ATLAS, the most commonly reported (>10%) adverse
events in patients treated with telavancin were taste disturbance, nausea,
vomiting, headache, and foamy urine.

MRSA: A Growing Global Epidemic

An estimated 1.2 million hospitalized patients in the United States may
be infected with MRSA, a type of bacteria that is resistant to antibiotics
commonly used to treat staphylococci infections. In the healthcare setting,
the proportion of resistant infections has grown. In 2004, according to the
Centers for Disease Control (CDC), MRSA infections accounted for
approximately 63 percent of the total number of staphylococci infections.
Over the last five years, MRSA infections have increased nearly ten-fold
and currently represent more than 50 percent of emergency department
cSSSIs. Data from a 2003 CDC study suggests that about 12 percent of
clinical MRSA infections are community-associated.

About Telavancin Collaboration

In November 2005, Theravance entered into a collaboration arrangement
with Astellas Pharma Inc. (Astellas) for the development and
commercialization of telavancin worldwide except Japan. In July 2006,
Theravance and Astellas expanded the collaboration to include Japan. Under
the terms of the collaboration, Theravance will lead the development of
telavancin for the treatment of cSSSI and hospital-acquired pneumonia, and
will collaborate substantially with Astellas in marketing in the United
States for the first three years. Astellas will lead all other development,
regulatory, manufacturing, sales and marketing activities.

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally
discovered product candidates. Theravance is focused on the discovery,
development and commercialization of small molecule medicines across a
number of therapeutic areas including respiratory disease, bacterial
infections and gastrointestinal motility dysfunction. Of the five programs
in development, four are in late stage -- its telavancin program focusing
on treating serious Gram-positive bacterial infections with Astellas Pharma
Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair
collaboration with GlaxoSmithKline plc and TD-1792 for the treatment of
serious Gram-positive infections. By leveraging its proprietary insight of
multivalency toward drug discovery focused on validated targets, Theravance
is pursuing a next generation strategy designed to discover superior
medicines in large markets. For more information, please visit the
company's web site at http://www.theravance.com.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S.
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical products.
The organization is committed to becoming a global category leader in
focused areas by combining outstanding R&D and marketing capabilities. In
the U.S., Astellas markets products in the areas of immunology, urology,
anti- infectives, cardiovascular and dermatology. For more information
about Astellas Pharma US, Inc., please visit our website at
http://www.astellas.com/us.

Trademarks listed belong to their respective owners.

This press release contains certain "forward-looking" statements as
that term is defined in the Private Securities Litigation Reform Act of
1995 regarding, among other things, statements relating to goals, plans,
objectives and future events. Theravance intends such forward-looking
statements to be covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Exchange Act and the Private
Securities Litigation Reform Act of 1995. Examples of such statements
include statements relating to the goals, timing and expected results of
regulatory review, statements regarding the potential benefits and
mechanisms of action of drug candidates, the enabling capabilities of
Theravance's approach to drug discovery and its proprietary insights, and
statements concerning expectations for product candidates through
development and commercialization. These statements are based on the
current estimates and assumptions of the management of Theravance as of the
date of this press release and are subject to risks, uncertainties, changes
in circumstances, assumptions and other factors that may cause the actual
results of Theravance to be materially different from those reflected in
its forward-looking statements. Important factors that could cause actual
results to differ materially from those indicated by such forward-looking
statements include, among others, risks related to delays or difficulties
in commencing or completing clinical and preclinical studies, the potential
that results of clinical or preclinical studies indicate product candidates
are unsafe, ineffective, inferior or not superior, delays or failure to
achieve regulatory approvals, and risks of collaborating with third parties
to develop and commercialize products. These and other risks are described
in greater detail under the heading "Risk Factors" contained in Item 1A of
Theravance's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 8, 2007 and the risks discussed in our
other filings with the SEC. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. Theravance assumes no
obligation to update its forward-looking statements.

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